Turck Dominique, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Kearney John, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Schlatter Josef Rudolf, van Loveren Henk, Gelbmann Wolfgang, Knutsen Helle Katrine
EFSA J. 2020 Aug 28;18(8):e06196. doi: 10.2903/j.efsa.2020.6196. eCollection 2020 Aug.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of ' fruit extract' as a novel food (NF) for its use in food supplements. The NF concerns a hot water extract of sliced and dried fruits and peduncles of Thun. The production process is described in sufficient detail but contains contradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash. In addition, the NF contains small amounts of flavonoids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant secondary metabolites. Given these limitations, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chronic disease, such as liver malfunction. Limited information was provided on a history of consumption of fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel concludes that the safety of the NF has not been established.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品和食品过敏原专家小组（NDA）被要求就“水果提取物”作为新型食品（NF）用于食品补充剂的安全性发表意见。该新型食品是由Thun的切片和干燥水果及果柄的热水提取物组成。生产过程描述得足够详细，但在与新型食品的另一种成分混合方面存在相互矛盾的信息。该新型食品主要由碳水化合物（约90%）、约2%的蛋白质、5%的水分、少于1%的脂肪和约2%的灰分组成。此外，该新型食品还含有少量黄酮类化合物，如二氢杨梅素、杨梅素和槲皮素。专家小组指出了批量检测提供的关于近似分析和植物次生代谢物的数据的局限性。鉴于这些局限性，专家小组认为申请人提供的数据并未证明按照所述生产工艺生产的不同批次产品符合提议的规格。目标人群为一般成年人群，不包括孕妇、哺乳期妇女和患有慢性疾病（如肝功能不全）的人群。关于水果消费历史和韩国批准的一种提取物的信息有限。进行了多项毒理学研究。然而，研究报告无法证实测试项目是否代表该新型食品。申请人提供的一项人体研究也是如此。专家小组得出结论，该新型食品的安全性尚未确立。
